Effects of Albumin on Survival after a Hepatic Encephalopathy Episode: Randomized Double-Blind Trial and Meta-Analysis

No therapies have been proven to increase survival after a hepatic encephalopathy (HE) episode. We hypothesize that two doses of albumin could improve 90-day survival rates after a HE episode. Methods: (1) A randomized double-blind, placebo-controlled trial (BETA) was conducted in 12 hospitals. The...

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Autores principales:	Meritxell Ventura-Cots, Macarena Simón-Talero, Maria Poca, Xavier Ariza, Helena Masnou, Jordi Sanchez, Elba Llop, Núria Cañete, Marta Martín-Llahí, Alberto Amador, Javier Martínez, Ana Clemente-Sanchez, Angela Puente, Maria Torrens, Edilmar Alvarado-Tapias, Laura Napoleone, Mireia Miquel-Planas, Alba Ardèvol, Meritxell Casas Rodrigo, Jose Luís Calleja, Cristina Solé, German Soriano, Joan Genescà
Formato:	article
Lenguaje:	EN
Publicado:	MDPI AG 2021
Materias:	clinical trial meta-analysis albumin hepatic encephalopathy Medicine R
Acceso en línea:	https://doaj.org/article/dddca517500840e4ae7162cc143da209
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spelling	oai:doaj.org-article:dddca517500840e4ae7162cc143da2092021-11-11T17:32:25ZEffects of Albumin on Survival after a Hepatic Encephalopathy Episode: Randomized Double-Blind Trial and Meta-Analysis10.3390/jcm102148852077-0383https://doaj.org/article/dddca517500840e4ae7162cc143da2092021-10-01T00:00:00Zhttps://www.mdpi.com/2077-0383/10/21/4885https://doaj.org/toc/2077-0383No therapies have been proven to increase survival after a hepatic encephalopathy (HE) episode. We hypothesize that two doses of albumin could improve 90-day survival rates after a HE episode. Methods: (1) A randomized double-blind, placebo-controlled trial (BETA) was conducted in 12 hospitals. The effect of albumin (1.5 g/kg at baseline and 1 g/kg on day 3) on 90-day survival rates after a HE episode grade II or higher was evaluated. (2) A meta-analysis of individual patient’s data for survival including two clinical trials (BETA and ALFAE) was performed. Results: In total, 82 patients were included. Albumin failed to increase the 90-day transplant-free survival (91.9% vs. 80.5%, <i>p</i> = 0.3). A competing risk analysis was performed, observing a 90-day cumulative incidence of death of 9% in the albumin group vs. 20% in the placebo (<i>p</i> = 0.1). The meta-analysis showed a benefit in the albumin group, with a lower rate of clinical events (death or liver transplant) than patients in the placebo (HR, 0.44; 95% CI, 0.21–0.82), when analyzed by a competing risk analysis (90-days mortality rate of 11% in the albumin group vs. 30% in the placebo, <i>p</i> = 0.02). Conclusions: Repeated doses of albumin might be beneficial for patient’s survival as an add-on therapy after an HE episode, but an adequately powered trial is needed.Meritxell Ventura-CotsMacarena Simón-TaleroMaria PocaXavier ArizaHelena MasnouJordi SanchezElba LlopNúria CañeteMarta Martín-LlahíAlberto AmadorJavier MartínezAna Clemente-SanchezAngela PuenteMaria TorrensEdilmar Alvarado-TapiasLaura NapoleoneMireia Miquel-PlanasAlba ArdèvolMeritxell Casas RodrigoJose Luís CallejaCristina SoléGerman SorianoJoan GenescàMDPI AGarticleclinical trialmeta-analysisalbuminhepatic encephalopathyMedicineRENJournal of Clinical Medicine, Vol 10, Iss 4885, p 4885 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	clinical trial meta-analysis albumin hepatic encephalopathy Medicine R
spellingShingle	clinical trial meta-analysis albumin hepatic encephalopathy Medicine R Meritxell Ventura-Cots Macarena Simón-Talero Maria Poca Xavier Ariza Helena Masnou Jordi Sanchez Elba Llop Núria Cañete Marta Martín-Llahí Alberto Amador Javier Martínez Ana Clemente-Sanchez Angela Puente Maria Torrens Edilmar Alvarado-Tapias Laura Napoleone Mireia Miquel-Planas Alba Ardèvol Meritxell Casas Rodrigo Jose Luís Calleja Cristina Solé German Soriano Joan Genescà Effects of Albumin on Survival after a Hepatic Encephalopathy Episode: Randomized Double-Blind Trial and Meta-Analysis
description	No therapies have been proven to increase survival after a hepatic encephalopathy (HE) episode. We hypothesize that two doses of albumin could improve 90-day survival rates after a HE episode. Methods: (1) A randomized double-blind, placebo-controlled trial (BETA) was conducted in 12 hospitals. The effect of albumin (1.5 g/kg at baseline and 1 g/kg on day 3) on 90-day survival rates after a HE episode grade II or higher was evaluated. (2) A meta-analysis of individual patient’s data for survival including two clinical trials (BETA and ALFAE) was performed. Results: In total, 82 patients were included. Albumin failed to increase the 90-day transplant-free survival (91.9% vs. 80.5%, <i>p</i> = 0.3). A competing risk analysis was performed, observing a 90-day cumulative incidence of death of 9% in the albumin group vs. 20% in the placebo (<i>p</i> = 0.1). The meta-analysis showed a benefit in the albumin group, with a lower rate of clinical events (death or liver transplant) than patients in the placebo (HR, 0.44; 95% CI, 0.21–0.82), when analyzed by a competing risk analysis (90-days mortality rate of 11% in the albumin group vs. 30% in the placebo, <i>p</i> = 0.02). Conclusions: Repeated doses of albumin might be beneficial for patient’s survival as an add-on therapy after an HE episode, but an adequately powered trial is needed.
format	article
author	Meritxell Ventura-Cots Macarena Simón-Talero Maria Poca Xavier Ariza Helena Masnou Jordi Sanchez Elba Llop Núria Cañete Marta Martín-Llahí Alberto Amador Javier Martínez Ana Clemente-Sanchez Angela Puente Maria Torrens Edilmar Alvarado-Tapias Laura Napoleone Mireia Miquel-Planas Alba Ardèvol Meritxell Casas Rodrigo Jose Luís Calleja Cristina Solé German Soriano Joan Genescà
author_facet	Meritxell Ventura-Cots Macarena Simón-Talero Maria Poca Xavier Ariza Helena Masnou Jordi Sanchez Elba Llop Núria Cañete Marta Martín-Llahí Alberto Amador Javier Martínez Ana Clemente-Sanchez Angela Puente Maria Torrens Edilmar Alvarado-Tapias Laura Napoleone Mireia Miquel-Planas Alba Ardèvol Meritxell Casas Rodrigo Jose Luís Calleja Cristina Solé German Soriano Joan Genescà
author_sort	Meritxell Ventura-Cots
title	Effects of Albumin on Survival after a Hepatic Encephalopathy Episode: Randomized Double-Blind Trial and Meta-Analysis
title_short	Effects of Albumin on Survival after a Hepatic Encephalopathy Episode: Randomized Double-Blind Trial and Meta-Analysis
title_full	Effects of Albumin on Survival after a Hepatic Encephalopathy Episode: Randomized Double-Blind Trial and Meta-Analysis
title_fullStr	Effects of Albumin on Survival after a Hepatic Encephalopathy Episode: Randomized Double-Blind Trial and Meta-Analysis
title_full_unstemmed	Effects of Albumin on Survival after a Hepatic Encephalopathy Episode: Randomized Double-Blind Trial and Meta-Analysis
title_sort	effects of albumin on survival after a hepatic encephalopathy episode: randomized double-blind trial and meta-analysis
publisher	MDPI AG
publishDate	2021
url	https://doaj.org/article/dddca517500840e4ae7162cc143da209
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Effects of Albumin on Survival after a Hepatic Encephalopathy Episode: Randomized Double-Blind Trial and Meta-Analysis

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